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VITABIOTICS    WtjM

devil’s claw    Patient Information Leaflet

tablets    Devil’s Claw Root Extract 600mg

WHAT IS IN THIS LEAFLET

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

Please read this information carefully before you start taking these tablets.

It contains some important information about this product. Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or refer to a qualified healthcare practitioner.

1.    WHAT THIS product IS AND WHAT IT IS uSED FoR

This product contains Devil’s claw root extract.

It is a traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints. This is based on traditional use only.

2.    BEFORE YOU TAKE THIS PRODUCT Do not take this product if you:

•    Are allergic to any of the ingredients (see section 6)

•    Have ever had or have a stomach ulcer or duodenal ulcer

•    Are pregnant or breast-feeding

•    Are under the age of 18 years

Tell your doctor before taking this product if you:

•    Have heart problems and want to take this product

Consult your doctor or qualified healthcare practitioner if:

•    Your joint pain is accompanied by swelling of the joint, redness or fever

•    Your symptoms worsen or do not improve after four weeks

Driving or operating machines:

In rare cases this product may cause dizziness and drowsiness. If this happens to you, do not drive or use machines.

3. HOW TO TAKE THIS PRODUCT For oral use only.

Adults and the elderly:

Take one dose in the morning and one dose in the evening. You can take the tablets with or without food. Swallow the tablets whole with some water or other liquid. Do not chew. Do not exceed the stated dose.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time, it does not matter if you have missed a dose.

After taking this product

You must speak to a doctor or a qualified healthcare practitioner if your symptoms worsen, if they do not improve after four weeks or if side effects not mentioned in this leaflet occur.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this product can have possible side effects. These are listed below:

•    Digestive disorders - diarrhoea, feeling sick, being sick, abdominal pain

•    Central nervous system disorders - headache, dizziness

•    Skin disorders - allergic skin reactions such as rash and itching.

If any of the effects become troublesome or if you experience any other unexpected effects not listed in this leaflet, consult your doctor or pharmacist.

You must speak to a doctor or a qualified healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if any of the side effects become serious, or if you notice any side effects not mentioned in the leaflet.

5. HOW TO STORE THIS PRODUCT

Do not use your tablets after the expiry date which is stated on

the box and blister pack. VITABIOTICS

5. HOW TO STORE THIS PRODUCT (CONTINUED)

The expiry date refers to the last day of that month. Medicines should not be disposed of via waste water or household waste.

Return any out of date tablets to your pharmacist who will dispose of them.

Do not store above 25°C. Store in the original packaging. Keep the tablets out of sight and reach of children.

Keep your tablets in the packaging until it is time to take them.

6. FURTHER INFORMATION Active ingredient

Each film coated tablet contains 600mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H.zeyheri L.Decne, radix) (equivalent to 2100mg - 3000mg of Devil’s Claw root).

Extraction Solvent

Ethanol 60% V/V.

Excipients in the extract

Maltodextrin, Silica Colloidal Anhydrous.

Tablet Core

Maltodextrin, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid,

Magnesium Stearate, Silica Colloidal Anhydrous.

Tablet Coating

Hypromellose, Copper Chlorophyllin,

Titanium Dioxide (E171), Glycerol

The tablets are green coated and oval shaped.

This product is available in 30, 60 and 90 tablets.

Not all pack sizes are marketed.

If you would like further information about this product or for large print, Braille or audio version please contact:

Traditional Herbal Registration Holder:

Vitabiotics Ltd, 1 Apsley Way, London NW2 7HF Telephone: 020 8955 2662

Manufacturer:

Thompson & Capper Ltd, Hardwick Road,

Astmoor, Runcorn, Cheshire WA7 1PH.

Traditional Herbal Registration Number: THR 00387/0056

You can help make medicines safer by reporting any side effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively, you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call free phone 0800 100 3352 (available 10am - 2pm Monday - Friday).

This leaflet was revised in August 2011